Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected Mothers (PedVacc002)

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For safety and reactogenicity: Actively and passively collected data on adverse events. [ Time Frame: Up to 28 weeks after vaccination ]

Secondary Outcome Measures :

For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA. [ Time Frame: 1 week before and 1 week after vaccination ]

For immunogenicity to MVA.HIVA: Frequency of IFN-γ-producing cells determined in an ELISPOT assay after overnight stimulation with a pool of HIVA-derived peptides. [ Time Frame: Up to 24 weeks after vaccination ]

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Failure to receive all standard KEPI immunizations according to national immunization programme.

Weight for age z-scores outside of 2 standard deviations of normal at the time of vaccination.

Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory tract infection with or without low-grade febrile illness, i.e., temperature of <37.5 °C).

Axillary temperature of ≥ 37.5 °C at the time of vaccination.

Any clinically significant abnormal finding on screening from biochemistry or haematology by the time of vaccination.

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., egg products.

Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine.

Administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate.

Any history of anaphylaxis in reaction to vaccination.

Research Physician's assessment of lack of willingness by parents to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the infant's risk of suffering an adverse outcome.